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FDA 510(k)

MiCor A100 Wearable ECG Recorder

K-Number: K162665 · 2018-01-26

ApplicantMitac International Corp.
Decision Date2018-01-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MiCor A100 Wearable ECG Recorder is a medical device manufactured by Mitac International Corp.. It received FDA 510(k) clearance on 2018-01-26 under approval number K162665. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiCor A100 Wearable ECG Recorder?

MiCor A100 Wearable ECG Recorder is a medical device that received FDA 510(k) clearance on 2018-01-26. It is manufactured by Mitac International Corp.. The 510(k) number is K162665.

When was MiCor A100 Wearable ECG Recorder approved by the FDA?

MiCor A100 Wearable ECG Recorder received FDA 510(k) clearance on 2018-01-26, under approval number K162665.

What company makes MiCor A100 Wearable ECG Recorder?

MiCor A100 Wearable ECG Recorder is manufactured by Mitac International Corp..

What is the FDA product code for MiCor A100 Wearable ECG Recorder?

The FDA product code for MiCor A100 Wearable ECG Recorder is DPS.

Related Devices (Code: DPS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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